
Amgen Inc. (NASDAQ:AMGN) shares are down on Monday after the company announced topline results from a Phase 3 trial of TEPEZZA, which is administered via an on-body injector for patients with moderate-to-severe active Thyroid Eye Disease.
The Phase 3 TEPEZZA OBI trial met its primary endpoint, showing a statistically significant 77% proptosis (bulging eyes) response rate among participants during the 24-week placebo-controlled period.
The study demonstrated a mean proptosis reduction of -3.17 mm.
Last week, the U.S. Food and Drug Administration (FDA) warned about serious and sometimes fatal liver injuries tied to Amgen’s Tavneos (avacopan)
The agency cited postmarketing data that point to new safety concerns beyond those identified in clinical trials.
Tavneos, approved in October 2021, is used in combination with glucocorticoids and other therapies to treat adults with severe active ANCA-associated vasculitis, a rare autoimmune condition affecting small- to medium-sized blood vessels.
At $346.02, the stock is trading 0.0% above its 20-day simple moving average (SMA), suggesting a neutral short-term trend. It is also trading 0.0% below its 100-day SMA, indicating that the stock is currently in a consolidation phase, showing neither strong bullish nor bearish momentum.
Benzinga Edge scorecard for Amgen
The Verdict: Amgen’s Benzinga Edge signal reveals a balanced profile with strong quality metrics, but it faces challenges in value and growth, suggesting a cautious approach for investors.
AMGN Stock Price Activity: Amgen shares were down 0.40% at $346.80 at the time of publication on Monday, according to Benzinga Pro data.
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